Cusatuzumab in Combination With Background Therapy for the Treatment of Participants With Acute Myeloid Leukemia

Official Title

An Open-label, Multicentre, Phase 1b Study of JNJ-74494550 (Cusatuzumab; Anti-CD70 Monoclonal Antibody) in Combination With Background Therapy for the Treatment of Subjects With Acute Myeloid Leukemia

Summary:

The purpose of the study is to characterize safety and tolerability of cusatuzumab in combination with various therapies used to treat acute myeloid leukemia (AML).

Trial Description

Primary Outcome:

• Frequency and Severity of Adverse Events (AEs), Laboratory Abnormalities, and Physical Exam Findings as a Measure of Safety

• Serum Concentration of Cusatuzumab
• Number of Participants with Anti-cusatuzumab Antibodies
• Percentage of Participants with Complete Response (CR)
• Percentage of Participants with Complete Remission with Partial Hematological Recovery (CRh)
• Percentage of Participants with CR with Incomplete Recovery (CRi)
• Percentage of Participants with CR plus CRh
• Overall Response Rate (ORR)
• Percentage of Participants with CR without MRD
• Percentage of Participants with Negative MRD who Achieved CR, CRh, CRi, or Morphologic Leukemia-free State (MLFS)
• Cohort 2 and 3: Time to Response
• Cohort 2 and 3: Duration of Response
• Cohort 2 and 3: Red Blood Cell (RBC) or Platelet Transfusion Independence

View this trial on ClinicalTrials.gov